Evaluation of the Tolerance and Acceptability of Rasagiline in the Treatment of Early-stage Parkinson's Disease (ACTOR)

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Dose-titration: As specified in the SPC for pramipexole, the product will be administered in three daily doses, preferably with meals, and the treatment will begin with a dose-titration phase of three weeks' duration, during which time the dosage will be gradually increased.

On completion of the dose-titration phase, the minimum therapeutic dose of 1.5 mg per day must be achieved by all the patients. The patients who cannot achieve this dosage will be withdrawn from the study. The reason for stopping dose-titration (and leaving the study) will be detailed in the CRF.

Dosage:

The effective dosage of pramipexole should be adapted to the individual, depending on clinical response and tolerance, in successive stages of 0.75 mg at one-week intervals, without exceeding the maximum dose of 3 mg per day.

overall clinical impression evaluated by the doctor (CGI-I) and by the patient (PGI-I)

Global-Benefit-Risk (GBR)

Evaluation of resources

Analysis of the principal criterion:

Analysis of the principal criterion will be carried out with those patients from the intention-to-treat population for whom tolerance data is available in at least one visit after D0.

Comparative analysis The percentages of patients in the two treated groups who present with at least one significant adverse event will be compared using a Khi-2 test.

Logistic regression A logistic regression analysis will be performed in order to explain the presence/absence of a significant event. The nature of the treatment and the centre will act as explanatory variables, and the initial scores as covariates. Analyses will also be performed on quantitative variables (ANCOVA)

Evaluation of the Global Benefit-Risk (GBR) according to the model suggested by Chuang-Stein et al.

Number of subject required:

Calculation of the size is based on the hypothesis that the percentage of patients presenting with at least one significant adverse event during follow-up (principal evaluation criterion) will differ by 15% from one group to the other. With an alpha risk set at 5% and a beta ris kat 20%, the number of subjects required, calculated using the Casagrande et Pike formula, is 110 subjects per group.

The NSN was slightly overestimated in order to maintain the desired strength while taking into account the possibility of lost to follow-up, and was fixed at 240 patients.

the frequency of 'significant' adverse events up to week 15, defined as a serious adverse event, an adverse event requiring withdrawal of treatment (in the opinion of the investigator) or an event considered as serious by the patient.

Secondary Outcome Measures
:

percentage of patients with sleep disorders [ Time Frame: each visit ]

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Ages Eligible for Study:

18 Years to 70 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

male or female aged between 18 and 70

capable of reading and understanding the information leaflet given to him/her

signed an inform consent form

presenting with idiopathic Parkinson's disease with a Hoehn and Yahr score of ≤ 3

has never been given anti-Parkinson medication, or has been treated with L-Dopa, on condition that the total duration of treatment was less than twelve weeks at a dosage of under 200 mg, or has been treated with a dopamine agonist other than Pramipexole, on condition that:

either the patient is still in the dose-titration phase at the time of inclusion

or that the treatment was administered for less than six weeks and was completed two weeks before inclusion

Exclusion Criteria:

women who are pregnant, breastfeeding, or planning a pregnancy in the months after joining the study

women of reproductive age who have not undergone surgical sterilisation or who are not using a reliable method of contraception before joining the study and during the study

patient presenting with hepatic insufficiency

patient presenting with a concommitant illness which is considered significant by the investigator, after examination of the history, the patient's clinical condition, or on the basis on any additional examinations performed

patient presenting with a skin lesion considered to be suspect by the investigator and which has not been evaluated by a dermatologist

patient presenting with a contraindication to treatment with Rasagiline or Pramipexole (please see the SPC for the respective products)

patient treated with fuoxetine during the five weeks preceding inclusion

patient treated with fluvoxamine, pethidine, selegiline or any other MAOI during the two weeks preceding inclusion

patient who has had deep brain stimulation treatment

patient who might receive dextromethorphan or a sympathomimetic during the study